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Not yet recruiting NCT07752589

Microbiota in Neoadjuvant Chemoimmunotherapy for NSCLC

— Observational Non-Small Cell Carcinoma of Lung Gut Microbiomes Neoadjuvant Chemoimmunotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neoadjuvant chemoimmunotherapy.
Who it may be relevant to
Registry conditions: Non-Small Cell Carcinoma of Lung, Gut Microbiomes, Neoadjuvant Chemoimmunotherapy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Cohort Study Investigating Gut Microbiota as an Immunomodulatory Predictor of Response to Neoadjuvant Chemoimmunotherapy in Resectable Non-small-cell Lung Cancer

Overview

Locally advanced lung cancer (LALC) has poor prognosis despite multimodal therapies. Neoadjuvant chemoimmunotherapy is now standard for resectable stage II-IIIB NSCLC, but patient responses vary. The gut microbiota, a key immune regulator, has been linked to immunotherapy efficacy, with microbial diversity predicting ICI response and fecal microbiota transplantation improving outcomes. While most studies focus on advanced disease, the microbiota's role in LALC during neoadjuvant therapy remains unclear. Exploring its dynamics may uncover novel biomarkers and strategies to optimize treatment

Interventions

  • Drug Neoadjuvant chemoimmunotherapy
    neoadjuvant chemoimmunotherapy typically involves a PD-1 inhibitor-such as nivolumab, sintilimab, or camrelizumab-combined with platinum-based doublet chemotherapy (e.g., paclitaxel plus cisplatin for squamous cell carcinoma, or pemetrexed plus cisplatin for adenocarcinoma). The standard regimen includes three treatment cycles administered every three weeks, followed by surgical resection within 4-6 weeks. Some patients may receive up to one year of adjuvant immunotherapy postoperatively.

Primary outcome measures

  • Pathologic complete response (pCR) [Time frame: From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）]
Secondary outcome measures (5)
  • Major pathological response (MPR) [Time frame: From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）]
  • Radiological response [Time frame: From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）]
  • Immune-related adverse event (irAE) [Time frame: From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）]
  • gut microbiomes [Time frame: From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）]
  • Disease free survival (DFS） [Time frame: From the postoperative period through 1 year after surgery]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 80 years;
  • Newly diagnosed, driver gene-negative non-small cell lung cancer (NSCLC) confirmed by histopathology (Stage IIA-IIIB);
  • At least one measurable lesion as defined by RECIST version 1.1; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • No prior systemic therapy or radiotherapy;
  • Eligible for surgical resection and suitable for neoadjuvant immunotherapy or chemotherapy as determined by multidisciplinary evaluation;
  • Signed written informed consent prior to study participation;
  • Adequate pulmonary ventilation and diffusion function confirmed by pre-enrollment pulmonary function test to allow for surgical resection.

Exclusion criteria

  • Requirement for systemic glucocorticoid therapy or other immunosuppressive treatments;
  • Use of antibiotics or presence of infections requiring antibiotic therapy within the past 3 months;
  • Probiotic use within 3 months prior to enrollment;
  • Presence of obstructive pneumonia, cancerous cavitation, or active pulmonary tuberculosis;
  • Presence of bronchiectasis, concurrent pulmonary infections, pulmonary fibrosis, or uncontrolled diabetes mellitus;
  • Presence of a primary tumor in another organ;
  • Receipt of chemotherapy or any other cancer treatment prior to enrollment;
  • Confirmed brain metastases by contrast-enhanced MRI before enrollment;
  • Active or pre-existing autoimmune diseases;
  • Uncontrolled comorbidities including heart failure, uncontrolled hypertension, unstable angina, or interstitial lung disease;
  • Positive for hepatitis B surface antigen or detectable hepatitis C RNA requiring treatment;
  • Known history or positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
  • Pregnant or breastfeeding women;
  • Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT07752589 · KY2025-810-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗